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Dockets Management

Dockets Entered On September 11, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
1996N-0144 OTC-Colloidal Silver Ingredients or Silver Salts
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
2006P-0405 Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
2007D-0234 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
2007P-0093 Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
2007P-0094 Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the- counter
2007P-0297 Request to reconsider the failure to approve Provenge
2007V-0338 Variance for an Alternate Beam Attenuator
1978N-0038 Sunscreen Drug Products
EC 2376 Miss. Jenn Epstein Vol #: 161
EC 2377 Mrs. Marty Searle Vol #: 161
EC 2378 Miss. Myra Delzeit Vol #: 161
EC 2379 Ms. jennifer wong Vol #: 161
1996N-0144 OTC-Colloidal Silver Ingredients or Silver Salts
ANS 4 HFW-1 to Congress of the United States Vol #: 7
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
C 128 Anthony L. Young Vol #: 10
C 129 Juice Products Association Vol #: 10
C 130 Cosmetics, Toiletry, and Fragrance Association (CTFA) Vol #: 10
EC 411 Winston-Salem State University Vol #: 12
EC 412 American Association for Justice Vol #: 12
EC 413 National Milk Producers Federation Vol #: 12
EC 414 GMA/FPA Vol #: 12
EC 415 FAAN Vol #: 12
EC 416 International Formula Council Vol #: 12
EC 417 Natural Products Association Vol #: 12
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
EC 42 Mr. Daniel Waite Vol #: 16
EC 43 COPD Foundation Vol #: 16
EC 44 Alpha-1 Advocacy Alliance Vol #: 16
EC 45 Individual User of Maxair Autohaler Vol #: 16
EC 46 Ms. Bridget Lowery Vol #: 16
EC 47 Ms. Joanne Grace Vol #: 16
EC 48 Boehringer Inghelheim Pharmaceuticals, Inc. Vol #: 16
EC 49 Abbott Vol #: 16
EC 50 American Pharmacists Association (APhA) Vol #: 16
EC 51 International Pharmaceutical Aerosol Consortium Vol #: 16
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
EMC 211 Greg Baker Vol #: 1
EMC 212 Kamie Stoner Vol #: 1
EMC 213 Mary L. Stephens Vol #: 1
2006P-0405 Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
C 8 University of Pennylvania Medical Center Vol #: 2
2007D-0234 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
C 3 Henkel Corporation R&D Vol #: 1
2007P-0093 Refuse to approve CIP-TRAMADOL ER until Cipher complies with the investigations Reports to show the safety and effectiveness of the drug
LET 1 Jane A. Axelrad Vol #: 1
2007P-0094 Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the-counter
LET 1 Jane A. Axelrad Vol #: 1
2007P-0297 Request to reconsider the failure to approve Provenge
C 6 Robert L. Range Vol #: 1
C 7 Joe Nadolny Vol #: 1
2007V-0338 Variance for an Alternate Beam Attenuator
ACK 1 FDA/ DDM/ to Palomar Medical Technologies, Inc. Vol #: 1
VAR 1 Palomar Medical Technologies, Inc. Vol #: 1

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